Fresenius Medical Care North America
Form 483 issued August 13, 2020 · Ogden, Utah
- Inspection
- Aug 5 – Aug 13, 2020
- Observations
- 2
- Pages
- 3
- FEI number
- 1713747
In short: On August 13, 2020, FDA issued a Form 483 with 2 observations to Fresenius Medical Care North America in Ogden, Utah (FEI 1713747) after an inspection that ran Aug 5 – Aug 13, 2020. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Questions about this 483
What did FDA find at Fresenius Medical Care North America?
FDA listed 2 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Fresenius Medical Care North America inspected by FDA?
The inspection ran Aug 5 – Aug 13, 2020, and the Form 483 is dated August 13, 2020.
How do I get the full Form 483 for Fresenius Medical Care North America?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.